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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K840928
Device Name FACTOR DEFICIENT SUBSTRATE PLASMA VIII
Applicant
Diatech, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Diatech, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.7290
Classification Product Code
GGP  
Date Received03/02/1984
Decision Date 04/30/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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